The nationwide outbreak of fungal meningitis linked to products manufactured at the New England Compounding Center should prompt Congress to pass legislation giving FDA authority and resources to regulate compounding pharmacies, Sen. Richard Blumenthal (D-Conn.) told BioCentury This Week, BioCentury's public affairs television program. Contaminated methylprednisolone distributed by the compounding pharmacy has killed 14 people in 11 states, the CDC reported on Thursday.
Blumenthal said FDA has a responsibility to request both more legal authority and more resources. "This crisis creates a clear and urgent alarm for the need for more legislation, and I am hopeful that Congress will heed that warning," he said.
"Enhanced authority on the part of the FDA is necessary to protect patients from compounding centers that now produce 3% of all the drugs manufactured in the U.S.," Blumenthal said. He added that compounding centers "operate in a legal, regulatory black hole, a netherworld," as a result of a U.S. Supreme Court decision that "discourages effective inspections, quality reporting, oversight and scrutiny." In 2002, the Supreme Court upheld a ruling by the Ninth Circuit Court of Appeals that FDA lacks authority to ban compounding pharmacies from advertising their products.
